Responsable Affaires Réglementaires - Dispositif Médical H/F Excelya
- Dijon - 21
- CDI
- Temps partiel
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
- Exp. 10 ans min.
Les missions du poste
At Excelya, we are committed to fostering an environment defined byAudacity, Care, and Energy. As a Clinical Operations Lead , you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies.
This position offers a unique opportunity for a regulatory affairs Manager to lead strategic regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance.
You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of healthcare products.
Main responsibilities :
- Develop and implement regulatory strategies to support product development, registration, and market access activities
- Prepare, maintain, and update Technical Documentation in accordance with MDR 2017/745 requirements.
- Coordinate CE Marking activities
- Assess the regulatory impact of product changes throughout the product lifecycle.
- Ensure compliance with applicable standards and regulations, including MDR 2017/745, ISO 13485, and ISO 14971.
- Support Post-Market Surveillance (PMS), Vigilance, and Post-Market Clinical Follow-up (PMCF) activities.
- Participate in internal and external audits, inspections, and regulatory assessments.
- Interface with Competent Authorities, and external regulatory partners.
- Monitor and interpret regulatory developments and communicate potential impacts to stakeholders.
- Collaborate closely with Quality Assurance, R&D, Clinical, Manufacturing, and Marketing teams to ensure regulatory compliance.
- Provide regulatory guidance and training to cross-functional teams.
Le profil recherché
WhyJoinUs?
AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.
Here'swhatmakesusunique-
Weareayoung,ambitioushealthcompanyrepresenting900Excelyates,driventobecomeEurope'sleadingmid-sizeCROwiththebestemployeeexperience.Ourone-stopproviderservicemodel-offeringfull-service,functionalserviceprovider,andconsulting-enablesyoutoevolvethroughdiverseprojects.Workingalongsidepreeminentexperts,youwillhelpimprovescientific,operational,andhumanknowledgetoenhancethepatient'sjourney.
Excellingwithcaremeansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission.
About you
Education: Master's degree in life sciences, pharmacy, chemistry, or a related field
Experience: Proven experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, including involvement in global submissions and lifecycle management activities, experience in cross-functional collaboration or project coordination is a plus. At least 10 years of experience in QARA (Quality Assurance & Regulatory Affairs) within the medical device field. Significant experience with Class II medical devices.
Skills: Strong knowledge of regulatory requirements and submission processes, as well as post-approval activities, good understanding of quality systems and product development; excellent communication, stakeholder management, and organizational skills.
Languages: Fluent in English and French (written and spoken)
Bienvenue chez Excelya
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.
Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.
We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
Publiée le 11/09/2026 - Réf : be34929b-cff1-460c-ae42-af35f7068614
